Hepatitis C Virus (HCV)Phase 3BASISNCT01754974
Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C
A Phase 3 study testing Peginterferon Lambda-1a, Ribavirin and Peginterferon alfa-2a in people with Hepatitis C Virus (HCV), run by Bristol-Myers Squibb at 16 sites in 3 countries.
Trial summary
The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C Virus (HCV)
- What is being tested?
- Peginterferon Lambda-1a, Ribavirin and Peginterferon alfa-2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Mar 2013to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C, Genotype 1
- HCV RNA ≥100,000 IU/mL at screening
- Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
- Naïve to prior anti-HCV therapy
Who cannot join
- Infected with HCV other than Genotype 1
- Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody at screening
- Evidence of liver disease other than HCV
- Active substance abuse
- Use of hematologic growth factors within 90 days prior to study randomization
- Evidence of history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
South Korea8 sites
Local Institution
Chungcheongnam-do, 330-930
Local Institution
Daegu, 700-821
Local Institution
Gangwon-do, 200-704
Local Institution
Gyeonggi-do, 420-717
Local Institution
Gyeonggi-do, 463-707
Local Institution
Gyeongsangnam-do, 626-770
Local Institution
Incheon, 403-720
Local Institution
Seoul, 156-755
Mexico5 sites
Local Institution
Distrito Federal, Mexico City, 03720
Local Institution
Guadalajara, Jalisco, 44500
Local Institution
Guadalajara, Jalisco, 44650
Local Institution
México, State of Mexico, 06700
Local Institution
Mexico City, Mexico City, 07760
Czechia3 sites
Local Institution
Hradec Králové, 500 05
Local Institution
Prague, 140 00
Local Institution
Ústí nad Labem, 400 01
About this study
Official title: A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects
The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.
- Conditions
- Hepatitis C Virus (HCV)
- Being tested
- Peginterferon Lambda-1a, Ribavirin, Peginterferon alfa-2a
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon Lambda-1aBiological
Also called BMS-914143
RibavirinDrug
Also called Ribasphere
Peginterferon alfa-2aBiological
Also called Pegasys
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon Lambda-1a + Ribavirin | Experimental | Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks Receives: Biological: Peginterferon Lambda-1a; Drug: Ribavirin |
| Peginterferon alfa-2a + Ribavirin | Active comparator | Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks Receives: Drug: Ribavirin; Biological: Peginterferon alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects
- ANC = Absolute Neutrophil Count
- Hb = Hemoglobin
Measured: Up to 48 weeks of treatment
Secondary outcomes (6)
Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ)
Measured: At Post-Treatment Follow-up Week 24
Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)
Measured: On treatment Week 4 (of an up to 48-week treatment period)
Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment
Measured: Up to 48 weeks of treatment
Proportion of subjects with dose reductions through end of treatment
Measured: Up to 48 weeks of treatment
Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment
Measured: Up to 48 weeks of treatment
Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting
On-treatment IFN-associated symptoms are:
- Flu-like symptoms (as defined by pyrexia or chills or pain)
- Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
- Neurological symptoms (headache or dizziness)
- Constitutional symptoms (fatigue or asthenia)
- Psychiatric symptoms (depression or irritability or insomnia)
Measured: Up to 48 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754974
- Sponsor's protocol ID
- AI452-033
- Other IDs
- 2012-003508-11
- Acronym
- BASIS
- Status last verified
- Dec 2013
- First submitted
- 19 Dec 2012
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects
- ClinicalTrials.gov ID
- NCT01754974
- Acronym / sponsor ID
- BASIS / AI452-033
- Conditions
- Hepatitis C Virus (HCV)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon Lambda-1a + Ribavirin | Experimental | Biological: Peginterferon Lambda-1a, Drug: RibavirinPeginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks |
| Peginterferon alfa-2a + Ribavirin | Active comparator | Drug: Ribavirin, Biological: Peginterferon alfa-2aPeginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic hepatitis C, Genotype 1
- HCV RNA ≥100,000 IU/mL at screening
- Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
- Naïve to prior anti-HCV therapy
Key exclusion criteria (6 listed)
- Infected with HCV other than Genotype 1
- Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody at screening
- Evidence of liver disease other than HCV
- Active substance abuse
- Use of hematologic growth factors within 90 days prior to study randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon Lambda-1aAlso: BMS-914143 | Biological | Peginterferon Lambda-1a + Ribavirin |
| RibavirinAlso: Ribasphere | Drug | Peginterferon Lambda-1a + Ribavirin, Peginterferon alfa-2a + Ribavirin |
| Peginterferon alfa-2aAlso: Pegasys | Biological | Peginterferon alfa-2a + Ribavirin |
Primary outcome
Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects
Time frame: Up to 48 weeks of treatment
* ANC = Absolute Neutrophil Count * Hb = Hemoglobin
6 secondary outcomes
Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ)
Time frame: At Post-Treatment Follow-up Week 24
Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)
Time frame: On treatment Week 4 (of an up to 48-week treatment period)
Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment
Time frame: Up to 48 weeks of treatment
Proportion of subjects with dose reductions through end of treatment
Time frame: Up to 48 weeks of treatment
Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment
Time frame: Up to 48 weeks of treatment
Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting
Time frame: Up to 48 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peginterferon Lambda-1a, Ribavirin and Peginterferon alfa-2a in people with Hepatitis C Virus (HCV), run by Bristol-Myers Squibb at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea, Mexico, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects (time frame: Up to 48 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.